syngo Imaging XS — Class II medical device recall Z-2264-2012
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2012-09-05, distributed nationwide. There is a potential malfunction when using syngo Imaging XS, version VA70A or higher. In some situations it c
| Recall number | Z-2264-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2012-07-18 |
| Classified | 2012-08-24 |
| Reported by FDA | 2012-09-05 |
| Terminated | 2014-11-06 |
| Distributed | Nationwide (US) |
| Quantity | 52 |
| Reason classes | device malfunction |
| Model numbers | 10496279 |
Product
syngo Imaging XS. Radiological image processing system.
Reason for recall
There is a potential malfunction when using syngo Imaging XS, version VA70A or higher. In some situations it can happen that a miscalculation is done for the grey scale values in the functions "Regions of Interest", "Pixel Lens", "Edge Enhancement" and "Histograms".
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.